Rümeysa Geujar, Dilana Treffers, Maaike Roelofs, Anna van Dongen, Kalpana Ramkisoensing, Rixt Even, Huub H van Rossum
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引用次数: 0
摘要
目的:用于临床目的的家庭血液采样已经引起了人们的极大兴趣。本研究验证了最近开发的基于topper的毛细管血液采集程序,用于15种常用的化学分析。方法:共纳入120名研究参与者(21名健康志愿者和99名患者)。获得静脉样本,然后要求参与者通过Topper系统(SelfSafeSure blood Collection Devices)自行采集血液。采用Cobas Pro (Roche)系统对采集的血清进行15项常见临床化学分析及血清指标分析。Spearman相关分析、Passing-Bablok回归分析、Bland-Altman差异分析。采用基于生物变异的允许偏差标准(EFLM数据库)确定可比性。结果:在120例(94 %)中,有113例获得了允许分析至少一种分析物的样本。Bland-Altman差异分析显示,葡萄糖和未校正的AST不符合最小偏倚标准,肌酐和白蛋白在最小偏倚标准内,尿素和钙在理想偏倚标准内。ALP、校正AST、ALT、总HDL-和ldl -胆固醇、CRP、GGT、总蛋白和甘油三酯均在最佳偏倚标准内。结论:我们的研究表明,对于大多数(如果不是全部)被研究的分析物,自行采集的毛细血管血液可以作为静脉采样的可靠替代方法。基于样品处理前分析物的稳定性,家庭抽样似乎是这些分析物选择的可靠抽样选择。
Validation of (self-collected) capillary blood using a topper collection system as alternative for venous sampling for 15 common clinical chemistry analytes.
Objectives: Home blood sampling for clinical purposes has gained much interest. This study validates the recently developed Topper-based capillary blood collection procedure for 15 commonly used chemistry analytes.
Methods: A total of 120 study participants (21 healthy volunteers and 99 patients) were enrolled. A venous sample was obtained and then participants were asked to self-collect blood by the Topper system (SelfSafeSure Blood Collection Devices). Collected sera were analyzed for 15 common clinical chemistry analytes and the serum indices on a Cobas Pro (Roche) system. Spearman correlations, Passing-Bablok regression analysis, and Bland-Altman difference analysis were performed. Comparability was determined using allowable bias criteria based on biological variation (EFLM database).
Results: In 113 out of 120 (94 %) self-collections a sample was obtained that allowed for the analysis of at least one analyte. Bland-Altman difference analysis showed that glucose and uncorrected AST did not meet the minimum bias criterion, creatinine and albumin were within the minimum bias criterion and urea and calcium were within the desirable bias criterion. ALP, corrected AST, ALT, total- HDL- and LDL-cholesterol, CRP, GGT, total protein and triglycerides were all within the optimal bias criterion.
Conclusions: Our study demonstrates that self-collected capillary blood can be used as a reliable alternative to venous sampling for most, if not all, analytes studied. Based on the analyte stability prior to sample processing, home sampling appears to be a reliable sampling option for a selection of these analytes.
期刊介绍:
Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically.
CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France).
Topics:
- clinical biochemistry
- clinical genomics and molecular biology
- clinical haematology and coagulation
- clinical immunology and autoimmunity
- clinical microbiology
- drug monitoring and analysis
- evaluation of diagnostic biomarkers
- disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes)
- new reagents, instrumentation and technologies
- new methodologies
- reference materials and methods
- reference values and decision limits
- quality and safety in laboratory medicine
- translational laboratory medicine
- clinical metrology
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